Field of the Invention
This invention relates to medical kits for treating neoplastic tissue; and more particularly, to such medical kits arranged with componentry for fluorescein sodium (FNa)-based diagnosis and trichloroacetic acid (TCA)-based treatment of neoplastic tissue.
Description of the Related Art
Cervical cancer was the third most commonly diagnosed cancer in women in 2012, with an estimated 529,828 new cases worldwide and a 52% mortality rate globally. Complex diagnostic procedures and analysis laboratories are impracticable in many remote locales.
The current method for diagnosing cervical cancer is colposcopy in which acetic acid is used as a staining agent to visualize abnormal tissue. Meanwhile, current management of patients with cervical intraepithelial neoplasia (CIN) includes the following treatments: Loop Electrical Excision Procedure (LEEP), Cold Knife Conization (CKC), cryosurgery, laser ablation, or hysterectomy. These procedures lead to partial destruction of the cervix. At the very least, the destruction will render the patient's future colposcopies unsatisfactory because the physician will be unable to clearly visualize the squamocolumnar junction due to scarring. A more serious side effect is cervical incompetence, which poses the most impact to women of reproductive age who are still planning to have children. This destruction is of most concern for patients with recurrent disease because additional treatments on a shorter cervix are more challenging surgically. Such drastic treatment is recommended only when colposcopic acetic acid visualization indicates cervical neoplasia. However, such indication is generally only seen when the lesions are in an advanced stage when using acetic acid visualization, when it would have been preferable to diagnose and treat lower-grade lesions much earlier.
Despite its long history as a diagnostic procedure, colposcopy continues to have varying success. In conjunction with acetic acid, the sensitivity of colposcopy to distinguish normal from abnormal tissue is relatively high. The accuracy, however, to distinguish low-grade lesions from high-grade lesions and cancer remains low. Additionally, a substantial proportion of high-grade lesions may fail to be identified at colposcopy. In a most recent post hoc analysis of more than 47,000 women, approximately 20% additional CIN 2 or worse and CIN 3 or worse was identified in women who did not have a visible lesion on colposcopy. Therefore, the treatment of CIN I may be just as important as treating CIN II or III.
The low sensitivity to distinguish low-grade lesions from high-grade lesions and cancer suggests that a substantial number of women may be over-treated. Equally importantly, a substantial proportion of high-grade lesions may fail to be identified at colposcopy.
Additionally, inter-observer variable rates of 52.4% and 51.0% have also been described in previous studies.